NCT00329654

Brief Summary

This will be a prospective, randomized, single blinded, controlled study in a single center setting to assess the effect of either phototherapy with the Embar® light therapy or sham irradiation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 25, 2006

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

5.8 years

First QC Date

May 23, 2006

Last Update Submit

July 30, 2015

Conditions

Burns

Keywords

Burn wounds, light therapy

Outcome Measures

Primary Outcomes (1)

  • Wound closure

    At time T0

Secondary Outcomes (1)

  • Scar assessment

    1 month, 3 months, 6 months and 1 year after wound closure

Study Arms (1)

Embar® light therapy or sham irradiation

EXPERIMENTAL

Phototherapy with the Embar® light therapy or sham irradiation.

Procedure: Phototherapy with the Embar® light therapy or sham irradiation

Interventions

Phototherapy with the Embar® light therapy or sham irradiationPROCEDURE

Phototherapy with the Embar® light therapy or sham irradiation is followed.

Embar® light therapy or sham irradiation

Eligibility Criteria

Age2 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All burn wounds with flux values measured by Laser Doppler Imaging, corresponding with expected healing time between 14 and 21 days, flux values between 200 and 600 (Pink-Yellow-Green-Light Blue color)
  • All burn wounds with above mentioned values and a maximal size of 8 by 10 cm.
  • Wounds treated with a hydrocolloid gel prior to LDI
  • All assessments are done during first days before scanning
  • Patients wish and possibility to follow the complete treatment schedule till wound healing and participation on complete follow-up schedule
  • Informed consent has been obtained

You may not qualify if:

  • All burn wounds with flux values measured by Laser Doppler Imaging, corresponding with other healing times (Red and Dark blue color)
  • Impossibility to debride necrotic skin prior to LDI measurement
  • Wounds treated with other topical ointments than hydrocolloids
  • Not following the complete treatment schedule or missing some evaluations during the follow-up period
  • Patient has any condition(s) that seriously compromises the patient's ability to complete this study.
  • Patient has participated in another study utilizing an investigational drug or device within the previous 30 days
  • Patient has one or more medical condition(s), diabetes, including renal, hepatic, hematologic, neurologic, or immune disease that in the opinion of the investigator would make the patient an inappropriate candidate for this wound healing study
  • The plastic surgeon decides that surgery is necessary
  • Patients wish to terminate the study
  • No informed consent before start of the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Conditions

Burns

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Stan Monstrey, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2006

First Posted

May 25, 2006

Study Start

March 1, 2006

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

July 31, 2015

Record last verified: 2015-07

Locations

BE(1)